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December 11, 2010

FDA Looks To Review Risks Of Mercury Dental Fillings

by Sam Savage

US health regulators are looking for a second opinion on whether dental fillings that contain mercury are a risk to dental patients, especially in children and pregnant women.

Officials with the Food and Drug Administration said although there are no new scientific findings on the silver-colored cavity fillings, it wants feedback on methods it used last year to weigh available data and decide that the alloy is safe.

The agency released documents Friday ahead of a public meeting held on the issue. In the documents the agency said it would ask its panel of experts to assess how much mercury dental patients are exposed to and how much is acceptable.

The FDA declared the fillings as not a risk in July 2009. But a year earlier it had cautioned against their use in certain people who could be more vulnerable, such as pregnant women and children, due to the mercury"Ës risks.

The agency is now reopening the issue after four groups questioned its assessment and petitioned for another look. The panel of outside experts will consider available data on Tuesday and Wednesday of next week before offering recommendations.

"Based on its own review and feedback from the panel, FDA will decide whether to make changes to its regulation," Nancy Stade, deputy director of policy for the FDA's device center, told Reuters on Friday. "At this time, the FDA is not modifying its existing recommendations to consumers."

The concern with mercury, a known toxin, is whether the vapors released from the metal alloy in dental fillings are enough to cause harm such as brain or kidney damage.

While some experts and advocacy groups say data shows a clear link between mercury and side effects from dental fillings, industry groups and dentists say the evidence shows dental amalgam is safe.

The FDA could decide to continue backing the metal alloy fillings, continue to urge cautious use, or ban the products. A possible ban would affect dental filling makers such as Dentsply International and Danaher Corp's Kerr unit, as well as distributors like Henry Schein and Patterson Cos Inc.

The American Dental Association said earlier this month "there is no scientific reason to revisit" FDA's 2009 ruling and that the data has not changed since then.

But several groups are planning to hold protests outside the meeting seeking for a ban on the fillings. The issue is expected to draw four hours of public comments during the two-day meeting.

"Amalgam is a primitive, polluting, pre-Civil War device which no modern dentist uses," Charles Brown, the lawyer for the Consumers for Dental Choice advocacy group, told Reuters. But, he said, he is pleased to "see such serious questions" will be posed to the FDA panel.

While it currently backs the fillings, the FDA has changed how it regulated them. Products must carry warnings against use in poorly ventilated areas or in patients with mercury allergies.

About 50 percent of amalgam contains mercury, while the rest is silver and other metals. Millions of Americans have such lower-cost fillings to patch cavities in their teeth. Other options include tooth-colored composite resins, although there is also some concern they can contain bisphenol A (BPA), which has raised concerns as well.